Livonia Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Livonia Diagnostics, Inc.” (first 1984, latest 1985), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 20 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CIQ | Diazo, Ast/Sgot | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (15)
- Hematology (1)
Most recent Livonia Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852161 | SERUM IRON/VIBC REAGENT SET | JIY | 1985-06-10 | 21 |
| K844322 | SGOT REAGENT SET | CIQ | 1984-11-27 | 20 |
| K844283 | SGPT REAGENT SET | CKD | 1984-11-27 | 22 |
| K844237 | ALKALINE PHOSPHATASE REAGENT SET | CIO | 1984-11-20 | 19 |
| K844156 | UREA NITROGEN REAGENT SET | CDW | 1984-11-13 | 20 |
| K844182 | INORGANIC PHOSPHORUS REAGENT SET | CEO | 1984-11-09 | 14 |
| K843894 | HDL PRECIPATATING REAGENT SET | LBR | 1984-11-02 | 30 |
| K844075 | URIC ACID REAGENT SET | LFQ | 1984-10-30 | 11 |
| K844024 | CREATININE REAGENT SET | CGX | 1984-10-30 | 15 |
| K843895 | TOTAL CALCIUM REAGENT SET | CIC | 1984-10-30 | 27 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Livonia Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Livonia Diagnostics, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Livonia Diagnostics, Inc.” (first 1984, latest 1985), across 16 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Livonia Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Livonia Diagnostics, Inc. is 20 days.
Which FDA product codes appear under Livonia Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CDW (Diacetyl-Monoxime, Urea Nitrogen, 1); CEK (Biuret (Colorimetric), Total Protein, 1); CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus, 1).
Next steps
- See all 16 Livonia Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDW, Livonia Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.